The Quality Coordinator is responsible for implementing the quality management programs such as environmental monitoring program, raw material inspection program, etc. to ensure company’s quality standards and procedures are met at BlendHouse. Working within Quality and with other departments and teams, the Quality Coordinator ensures the company’s compliance with all applicable infant formula manufacturing regulations and standards.

The Quality Coordinator position is a hands-on, highly interactive role in a fast-paced, continually changing production environment. The Quality Coordinator must ensure that BlendHouse quality standards are consistently maintained and seek to drive continuous improvement of all aspects of the BlendHouse food safety and quality systems.

ESSENTIAL FUNCTIONS

• Maintenance the environmental sampling program to ensure that routine sample collection is performed at the locations and frequencies specified in the written procedures.
• Assist with raw material sampling, working closely with Logistics and Quality Laboratory. Submission of samples for testing per protocols to associated Laboratories, as required.
• Coordinate with external (contract) laboratories to manage sample submission and receipt of materials, and to ensure that outsourced test results are received in a timely manner.
• Interpret and evaluate the data for compliance with internal and regulatory standards and specifications. Analyze results to identify trends and provide summaries of environmental data and trends to management and appropriate departments.
• Participate in investigations relating to deviation and nonconformance.
• Assist in completing documentation including but not limited to: Event Reporting, Corrective Actions, Change controls, Hold Reports, SOP’s, and forms that meet Internal and Infant Formula Requirements.
• Participate in internal and external regulatory audits as required.
• Train and develop site staff as necessary.
• Follow all laboratory and plant GMP and safety procedures and company guidelines.
• Perform general lab and lab-related administrative functions, including cleaning and organization of the microbiology lab and ordering materials and supplies.
• Perform additional duties as requested by Quality management.

QUALIFICATIONS

To perform this job successfully, an individual must be extremely well-organized, detail-oriented, and accurate and be able to manage multiple projects and tasks simultaneously.

It is essential that job responsibilities are performed in a timely manner and documented correctly and accurately.

Education

Bachelor's degree required; concentration in microbiology, biology, or a related science preferred.

Experience

• 2-5 years of experience in food processing, pharmaceutical, or comparable federally-regulated environment; infant formula, dairy, or spray drying preferred.
• Working knowledge of HACCP principles. HACCP certification is a plus.
• Working knowledge of MS Office (Word, Excel, PowerPoint, Outlook) is required.

Requirements

The Quality Coordinator must have the ability to:

• Follow all established laboratory, environmental, regulatory, and safety procedures at all times, adhering to the standards of quality dictated by current GMP and the company Quality policies and site SOPs.
• Apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Work independently to organize and prioritize tasks and manage workload.
• Accurately complete required documentation, following Good Documentation Practices in all aspects and phases of the work. The ability to write legibly is a must.
• Maintain the safety and orderliness of the lab.
• Perform mathematical calculations.
• Work with other lab personnel on projects and elicit and/or delegate help as needed.

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Walk, stoop, bend, reach, and stand for extended periods of time.
• Climb up to 5 flights of stairs regularly.
• Lift up to 50 lbs. occasionally.
• Sit for long periods to work on a computer.
• Use hand-eye coordination and manual dexterity sufficient to perform sampling tasks, operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Wear personal protective equipment, including safety glasses, hair net, beard net (if applicable), gloves, specialized clothing including laboratory scrubs (pants and shirt) and lab coat, and appropriate shoes.
• Work in constrictive gowning, including facial masks, for extended periods of time.
• Must be able to work weekends and off-shift hours as needed to support manufacturing activities.
• Attendance is mandatory.